NANGEL

K083005 · Teknimed, S.A. · LYC · Mar 4, 2009 · Dental

Device Facts

• Record ID: K083005
• Device Name: NANGEL
• Applicant: Teknimed, S.A.
• Product Code: LYC · Dental
• Decision Date: Mar 4, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

HYDROXYLAPATITE GEL is designed as a material intended for filling osseous defects not intrinsic to bone stability. HYDROXYLAPATITE GEL is progressively reabsorbed and replaced by bone during the rehabilitation process. The use of HYDROXYLAPATITE GEL is recommended for: Dental or maxillo-facial surgery: - Filling after surgical curettage (cysts or benign tumors) - Osseous defects caused by a traumatic bone lesion. - Treatment of alveolar wall and crest defects

Device Story

HYDROXYLAPATITE GEL is a bone graft substitute material. It is applied by clinicians during dental or maxillo-facial surgical procedures to fill non-load-bearing osseous defects. The material is designed to be progressively reabsorbed by the body and replaced by natural bone tissue during the patient's healing and rehabilitation process. It serves as a scaffold for bone regeneration in sites such as post-curettage cavities, traumatic lesions, and alveolar defects.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory review of device characteristics and intended use.

Technological Characteristics

Bone graft material composed of hydroxylapatite in a gel carrier. Designed for progressive reabsorption and replacement by host bone. Non-load-bearing application.

Indications for Use

Indicated for filling osseous defects not intrinsic to bone stability in dental or maxillo-facial surgery, including post-curettage (cysts/tumors), traumatic bone lesions, and alveolar wall/crest defects.

Regulatory Classification

Identification

Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.

Special Controls

*Classification.* (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is a common symbol associated with healthcare and medicine. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAR - 4 2009

Teknimed, S.A. C/o Mr. J.D. Webb Official Correspondent The OrthoMedix Group, Incorporated 1001 Oakwood Boulevard Round Rock, Texas 78681

Re: K083005

> Trade/Device Name: HYDROXYLAPATITE GEL Regulation Number: 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: February 18, 2009 Received: February 23, 2009

Dear Mr. Webb:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{1}------------------------------------------------

Page 2 - Mr. Webb

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000~1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Syring. Michai Ond.

Ginette Y. Michaud. M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known): _

Device Name: _ HYDROXYLAPATITE GEL

Indications for Use:

HYDROXYLAPATITE GEL is designed as a material intended for filling osseous defects not intrinsic to bone stability. HYDROXYLAPATITE GEL is progressively reabsorbed and replaced by bone during the rehabilitation process. The use of HYDROXYLAPATITE GEL is recommended for:

Dental or maxillo-facial surgery:

- Filling after surgical curettage (cysts or benign tumors)
- Osseous defects caused by a traumatic bone lesion.
- Treatment of alveolar wall and crest defects

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Shuak Rumer

(Division Sign-Off) Division of Anesthesiology, General Hospital Intection Control, Dental Devices

ROXBORO